1. Field of the Invention
This invention relates to medical devices in general and, more particularly, to hemostatic devices. The device is particularly useful for arresting the flow of blood or hemorrhage from punctures of the vascular system.
2. Background Art
Various surgical procedures are performed by medical specialists such as cardiologists, utilizing percutaneous entry into a blood vessel or body cavity. Examples of such procedures include different techniques to recanalize atherosclerotic blood vessels, such as balloon angioplasty or atherectomy. Recently, both the types and number of procedures performed utilizing the above mentioned percutaneous access to blood vessels have increased greatly.
These procedures generally involve the percutaneous puncture with a thin walled needle into a blood vessel. Following this, a guidewire is placed through the needle into the blood vessel and the needle is withdrawn. An intravascular sheath of variable size is then advanced over the guidewire, percutaneously, into the lumen of the blood vessel. The introducer sheath is then used as an ingress/egress means during the procedure. Following completion of the procedure, the introducer sheath may be removed, but this requires the application of prolonged manual pressure over the puncture site by a physician or other suitably trained medical personnel. The time involved here is frequently extensive since patients are often treated with a variety of anticoagulant and thrombolytic agents, particularly in the setting of a heart attack. Alternatively, the sheath may be left in the puncture site for a prolonged period of time until the patient's coagulation status has returned to normal. Depending on the size of the vascular sheath, there may be an increased risk of bleeding to the patient, which may require blood transfusion. In addition, there is a significant risk for injury to the blood vessel upon removal of the sheath, particularly if the sheath has been in place for a prolonged period of time. This includes the possible development of an pseudo-aneurysm or severe hematoma. The current technique for removal of introducer sheaths is also painful to the patient and requires prolonged bed rest after removal. This adds to the discomfort for the patient, as well as prolonging hospitalization and costs.
Many of the intra-vascular procedures are performed in patients who are clinically unstable or who have the potential to become so, following completion of the procedure. Following removal of the vascular access sheath, it could be cumbersome and sometimes difficult to re-enter the blood vessel if necessary. Thus, with the current technique for removal of the sheath following the procedure, no easy, reliable method is available to allow reaccess to the lumen of the blood vessel, if necessary.
In the past, various devices and methods have been used and proposed in an attempt to seal punctures in blood vessels by injection of a resorbable hemostatic plug into the puncture site. U.S. Pat. No. 4,744,364 (Kensey), U.S. Pat. No. 4,852,568 (Kensey), and U.S. Pat. No. 4,890,612 (Kensey) disclose such a method and device. These prior art devices and methods have a number of shortcomings and problems. Specifically, they involve injection of a foreign pharmacologic material into the vasculature to induce hemostasis. Once the prior art device is employed, it cannot be removed without surgical intervention and, if it has not been placed correctly or has been injected into the vascular lumen, it could cause complications such as vascular occlusion. The prior art devices do not provide the capability of reentry into the blood vessel lumen, when necessary, if a change occurs in the patient's clinical status. The prior art does not teach the use of simple nonsurgical means for effecting the closure of a puncture in a blood vessel by using an expandable balloon to plug the opening, and without requiring sutures or the application of prolonged manual pressure.
Despite the need for a device and method in the art which overcomes the limitations and problems of the prior art, none insofar as is known has been proposed or developed. The present invention is specifically directed to overcoming all of the problems previously enumerated regarding the performance of invasive vascular procedures through a percutaneously placed sheath.